Do any of you is complying with FDA 21 CFR part 11 using RTC?

Alvaro Riera (40●1●12●18) | asked Nov 04 '13, 5:55 a.m.

Morning, i have an RTC doubt.

We need to comply with FDA 21 CFR part 11 in one of our projects.

I have configured RTC e-signature to request password in state changes and in aprovals, reviews, etc...

Just wanna know if its enough to comply with FDA 21 CFR part 11 based in your experience :)

Tyvm.

Comments

Paul Spalitta commented Oct 12 '15, 9:26 p.m.

Did you finish qualifying RTC as 21 CFR Part 11 compliant?

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